A Kidney Transplant Study to Look at the Effects of Taking Fixed Doses of CellCept Versus Taking Doses of CellCept Based on the Concentration of CellCept in the Blood When Taking Full or Reduced Dose Calcineurin Inhibitors
Primary Purpose
Kidney Transplantation, Delayed Graft Function
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
CellCept
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Transplantation focused on measuring Kidney Transplant
Eligibility Criteria
Inclusion Criteria: Participants must be between 18 and 70 years of age and should be receiving their first or second kidney transplant.
Sites / Locations
- Mayo Clinic
Outcomes
Primary Outcome Measures
Treatment failure defined as a biopsy proven acute rejection, graft loss, death, or lost to follow-up
Assessment of renal function
Secondary Outcome Measures
The proportion of patients experiencing biopsy proven acute rejections
The total number of biopsy proven, acute rejection episodes, per patient
The proportion of patients treated for acute rejection
The time to the first proven acute rejection
The time to the treatment failure
Full Information
NCT ID
NCT00217152
First Posted
September 20, 2005
Last Updated
December 16, 2011
Sponsor
Mayo Clinic
Collaborators
Roche Pharma AG
1. Study Identification
Unique Protocol Identification Number
NCT00217152
Brief Title
A Kidney Transplant Study to Look at the Effects of Taking Fixed Doses of CellCept Versus Taking Doses of CellCept Based on the Concentration of CellCept in the Blood When Taking Full or Reduced Dose Calcineurin Inhibitors
Official Title
An Open Label, Prospective, Randomized, Controlled, Multicenter Study Assessing Fixed Dose vs. Concentration Controlled CellCept Regimens for Patients Following a Single Organ Renal Transplantation in Combination With Full Dose and Reduced Dose Calcineurin Inhibitors
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Terminated
Why Stopped
Roche decided to prematurely terminate study.
Study Start Date
March 2005 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
Collaborators
Roche Pharma AG
4. Oversight
5. Study Description
Brief Summary
This research is being done to study the effects (good and bad) of taking CellCept based on blood concentrations versus taking a fixed dose of CellCept without measuring the blood concentration. CellCept is one of the three immunosuppressant drugs (drugs that suppress the immune system) which will be taken as part of this kidney transplant study. Cyclosporine or tacrolimus and corticosteroids are the two other drugs which will be taken.
Detailed Description
This study is an open label study, which means the participant will know which drugs they are on. Participants will be put in one of three groups within 24 hours of the participant's transplant. The participant will be asked to return throughout the 24 months for physical exams, blood and urine tests.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplantation, Delayed Graft Function
Keywords
Kidney Transplant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
CellCept
Primary Outcome Measure Information:
Title
Treatment failure defined as a biopsy proven acute rejection, graft loss, death, or lost to follow-up
Time Frame
during the first 12 months following randomization
Title
Assessment of renal function
Time Frame
12 months post randomization
Secondary Outcome Measure Information:
Title
The proportion of patients experiencing biopsy proven acute rejections
Title
The total number of biopsy proven, acute rejection episodes, per patient
Title
The proportion of patients treated for acute rejection
Title
The time to the first proven acute rejection
Title
The time to the treatment failure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants must be between 18 and 70 years of age and should be receiving their first or second kidney transplant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark D. Stegall, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Kidney Transplant Study to Look at the Effects of Taking Fixed Doses of CellCept Versus Taking Doses of CellCept Based on the Concentration of CellCept in the Blood When Taking Full or Reduced Dose Calcineurin Inhibitors
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